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REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER INDIAN REGULATORY AUTHORITIES, EUROPEAN COMMUNITY, UNITED STATES AUTHORITIES:

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER INDIAN REGULATORY AUTHORITIES, EUROPEAN COMMUNITY, UNITED STATES AUTHORITIES Under the guidance of Mr.CH.M.M.Prasad Rao M.Pharm Department of Pharmaceutical Analysis And Quality Assurance Submitted By Arun Kumar Undavalli QIS College Of Pharmacy Vengamukkapalem Ongole

Topics to be covered:

Topics to be covered (1) REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER INDIAN REGULATORY AUTHORITIES. (2) REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER EUROPEAN COMMUNITY. (3) REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER UNITED STATES AUTHORITIES. (4) Guidelines And Stability Protocols For Different Pharamceutical Dosage Forms

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER INDIAN REGULATORY AUTHORITIES:

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER INDIAN REGULATORY AUTHORITIES For parental products specific consideration needs to be included for isotonicity, emulsion globule size , ease of re suspension & sedimentation rate , particle size &size distribution, viscosity & syringe ability, crystal changes. Full consideration should include the proposed instructions for dilution (or) re constitution of products of compatibility with the proposed solvents (or) diluents . This include a demonstration that the proposed storage temperature & extremes of concentration are suitable. (4) Preservative efficacy aspects should be included but allowed for large volume parental. (5) Microbial contamination issues are particularly significant for excipients to be used in sterile products. (6) Compatibility data should be considered in formulation of injections.

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER EUROPEAN COMMUNITY. :

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER EUROPEAN COMMUNITY. For parental products specific consideration needs to be included for isotonicity , emulsion globule size , ease of re suspension & sedimentation rate , particle size &size distribution, viscosity & syringe ability, crystal changes. (2) Full consideration should include the proposed instructions for dilution (or) re constitution of products of compatibility with the proposed solvents (or) diluents . (3) This include a demonstration that the proposed storage temperature & extremes of concentration are suitable. (4) The preservation efficacy aspects of parental products are particularly important for those products that are permitted to contain preservatives. (5)It is not allowed for large volume parental injections (or) for any product gaining access the cerebro spinal fluid (or) for intra (or) rectro- ocular injection. (6) Preserved products should be labeled to state this un-equivocally.

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER UNITED STATES AUTHORITIES.:

REULATORY REQUIREMENTS INVOLVED IN INJECTIONS AS PER UNITED STATES AUTHORITIES. (1) The physiochemical properties of pure drugs & the study of its properties in the presences of desired selected excipents is essential for development of stable, effective & safe parental formulation. (2) The properties should exaggerated conditions of temperature, light, humidity & oxygen are necessary to select the suitable excipients, optimization of excipients concentration, selection of packaging materials & to specify the adequate storage conditions . (3) The solubility & stability of the compound can predicted from the structure & molecular weight of active ingredient. (4) The extent of saturation can be noticed by observing the color of the active ingredient, odour of the compound allows the prediction of certain functional groups &presences of residual solvents. Change color & may indicate the status of stability. (5) The microscopic properties are important in case of parental suspensions & reconstituted solids like crystal size, size distribution & density. The rate of solution, the fill volume, & duration of action of parental suspension is more often decided by dispersed drug particle size.

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(6) Extended insulin zinc suspension contains large crystals of zinc complex & prompt insulin zinc suspension contains small insulin zinc suspension . (7 ) The solubility , dissolution rate & stability of the drug in the vehicle differs & conversion occurs from one polymorph to another form alters the physico chemical properties of chemical properties. (8 ) The selection of suitable polymorph & maintenance of desired conditions for prevent ion of one polymorph from another is essential in formulation of parental formulation. (9) The solubility , stability & flow properties of the solid drug are decided by ability of the compound to absorb the moisture from surrounding environment. (10 ) Selection of excipients & packaging materials is often decided by the hygroscopic potential of the drug . It is determined by exposing the drug to different relative humidity (90%, 80%, &60%RH) for a period of two weeks. (11) Higher solubility is required to formulate acceptable formulation for I.M & I.V so that they may be incorporated in small volume of vehicle.

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(12 ) The solubility is to be reduced to enhanced stability of drugs to enhance stability of the drugs like penicillin . Buffers , salt form , co solvents, complexing agent &prod rug approach are to modify the solubility. (13 )To modify the solubility & stability of the compound p H solubility profile pH stability profiles are desired . The optimum pH favoring &solubility / stability should be identified & maintained in the formulation to extend the shelf life & to improve the efficacy & safety of the formulation . (14) Compatibility studies should be carried out .